UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002351 |
|---|---|
| Receipt number | R000002886 |
| Scientific Title | Effect of Cilostazol compared with Clopidogrel about prevention of myocardial injury after elective percutaneous coronary intervention :Prospective,Randomized,Open,Blinded-Endpoint trial |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2013/03/19 13:38:14 |
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Basic information
Public title
Effect of Cilostazol compared with Clopidogrel about prevention of myocardial injury after elective percutaneous coronary intervention
:Prospective,Randomized,Open,Blinded-Endpoint trial
Acronym
ECARTE trial
Scientific Title
Effect of Cilostazol compared with Clopidogrel about prevention of myocardial injury after elective percutaneous coronary intervention
:Prospective,Randomized,Open,Blinded-Endpoint trial
Scientific Title:Acronym
ECARTE trial
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify to what extent cilostazol and clopidogrel can prevent myocardial injury after elective PCI.
Although the labels of drug-eluting stents recommend the use of clopidogrel with aspirin, the preventive effect with regard to myocardial injury is unclear. On the other hand, because cilostazol combines an antiplatelet effect with an improvement of the endothelial function and an increase in the level of adenosine in the blood, it is usually expected that administration of cilostazol prior to and after PCI reduces the risk of myocardial injury. However, it is not clear which of the two drugs reduces the risk of myocardial injury and leads to an improvement in prognosis. The present study is expected to establish the best antiplatelet therapy to be used as pharmacological treatment before and after PCI.
In addition, this study provides valuable basic data for the evaluation of adjunctive pharmacological treatments before and after PCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Frequency of increase of troponin-I above the upper limit of normal
2.Frequency of increase of CK >2 times above the upper limit of normal
3.Frequency of increase of CK-MB>2 times above the upper limit of normal
4.Average value of cardiac enzymes (CK/CK-MB/troponin-I)
5.Average rate of change of cardiac enzymes (CK/CK-MB/troponin-I)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be given Aspirin 100mg + cilostazol 200mg orally twice daily. Both drugs will be administered to patients starting seven days or more prior to PCI.
Interventions/Control_2
Patients will be given Aspirin 100mg orally once daily + clopidogrel 75mg orally once daily. Both drugs will be administered to patients starting seven days or more prior to PCI.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with stable angina
(2) Patients who will undergo PCI (Only those who use bare-metal stents)
Key exclusion criteria
(1)Patients with unstable angina
(2)Patients who use drug-eluting stents (DES)
(3)Patients with a medical history of acute myocardial infarction within three months
(4)Patients whose levels of CK and CK-MB,troponin-I are above upper limits of normal at the time of consent acquisition
(5)Patients taking an anticoagulant (warfarin)
(6)Patients who have a medical history of hypersensitivity to cilostazol, aspirin, and/or clopidogrel
(7)Patients with thrombocytopenia
(8)Patients with hepatic dysfunction (AST (GOT) or ALT(GPT) > 100 IU/L within three months)
(9)Patients with renal dysfunction (serum creatinine >2.0mg/dl within three months)
(10)Patients with congestive heart failure
(11)Patients who are pregnant
(12)Patients with bleeding
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishii |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 19 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002886
